一个修改后的Delphi研究,以建立基本的临床药理学能力
Bernadette Johnson-Williams1,2, Kellie Reynolds3, Joga Gobburu4
1Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. Bernadette.johnson-williams@fda.hhs.gov.
Therapeutic innovation & regulatory science
|February 6, 2024
概括
这项研究确定了临床药理学家在监管角色中的基本核心和技术能力. 德尔菲技术有效地确定了支持不断发展的药物开发工作人员所需的关键技能.
科学领域:
- 临床药理学 临床药理学
- 药物开发 药物开发
- 监管科学 监管科学
背景情况:
- 基于能力的教育对于医疗保健工作人员的发展至关重要.
- 临床药理学对于药物开发至关重要,影响医疗保健和公共卫生.
- 对于新兴药物开发趋势而言,具有足够技能的临床药理工作人员是必不可少的.
研究的目的:
- 在监管环境中确定临床药理学家最重要的能力.
- 建立关于临床药理工作人员必需技能的共识.
主要方法:
- 一种两轮修改的Delphi技术,涉及来自临床药理学办公室 (OCP) 的29名临床药理学家.
- 电子问卷使用SurveyMonkey®与利克特级别排名来评估核心和技术能力.
- 共识定义为60%的同意,数据使用描述性统计和麦克纳马变化测试进行分析.
主要成果:
- 在第一轮中,所有56个核心和技术能力都被认为是必不可少的,至少有60%的共识.
- 在第二轮中,62个能力被列为必不可少的,至少有60%的共识.
- 麦克纳马的更换测试证实了两轮之间的能力排名的稳定性.
结论:
- 基本的核心和技术能力可以为临床药理工作人员的教育计划提供信息.
- 德尔菲技术通过促进专家共识,有效地确定基本能力.
- 这项研究为在监管环境中维持临床药理工作人员提供了基础.
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